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OsteoarthritisOANCT01836380

Regular Swimming, Vascular Function, and Arthritis

A study testing Exercise Training in people with Osteoarthritis, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypothesis #1: The investigators hypothesize that both swimming training and cycling training will demonstrate significant improvements in endothelium-mediated vasodilation and central artery compliance in this population and that there will be no difference in the magnitude of increases between the water-based and… Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Osteoarthritis
What is being tested?
Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
Jan 2013to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All the subjects will have a radiological diagnosis of osteoarthritis according to American College of Rheumatology criteria
  • Subjects will be sedentary (i.e., no regular physical activity for at least the prior 1 year)

Who cannot join

  • Subjects with significant intima thickening,
  • plaque formation, and/or characteristics of atherosclerosis.
  • unstable cardiac or pulmonary diseases.
  • joint replacement surgery in the previous year.
  • intraarticular injection nor systemic steroids within previous 3 months.
  • severe disabling co-morbidity that disallows receiving exercise therapy.
Show all 10Show fewer
  • excess alcohol use (>21 drinks/week).
  • unwillingness to perform exercise.
  • fear of water.
  • mental incapability

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas at Austin

    Austin, Texas, 78712

Other trials in United States

About this study

Official title: Effects of Swimming Exercise and Cycling Exercise Interventions on Vascular Function, Inflammation and Pain in Middle-aged and Older Adults With Osteoarthritis.

Hypothesis #1: The investigators hypothesize that both swimming training and cycling training will demonstrate significant improvements in endothelium-mediated vasodilation and central artery compliance in this population and that there will be no difference in the magnitude of increases between the water-based and land-based exercise interventions.

Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent vasodilation and arterial compliance in response to exercise training interventions will be related to the corresponding reductions in inflammatory biomarkers.

Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling exercise will improve functional capacities and disease progression in middle-aged and older adults with osteoarthritis.

Read the detailed description

Middle-aged and older men and women (40-90 years old) of all races and ethnic backgrounds will serve as subjects after obtaining their written, informed consent. All the subjects will have a radiological diagnosis of osteoarthritis according to American College of Rheumatology criteria.

Conditions
Osteoarthritis
Being tested
Exercise Training
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01836380
Study groupRoleWhat they receive
Swimming TrainingExperimentalThe swimming training will be performed at two swimming pools on the campus of The University of Texas at Austin (University Aquatic Center or Gregory Gym pool). In the first 2-3 weeks a swimming instructor will provide personalized skill feedback to the subjects in the swim training group. Subjects will swim 15-20 minutes/day at a relatively low intensity of exercise while they receive swimming skill instructions. As their overall level of fitness and exercise skill improve, the intensity and duration of exercise will increase to 40-45 minutes/day at a moderate intensity of 70-75% of maximal heart rate. Exercise training will be performed three days per week.
Receives: Behavioral: Exercise Training
Cycling TrainingExperimentalThe cycling training will be conducted in the newly-constructed Exercise Training Intervention Core-Laboratory in the Department of Kinesiology and Health Education on the University of Texas campus. In the first 2-3 weeks a cycling instructor will provide personalized skill feedback to the subjects in the cycle training group. Subjects will cycle 15-20 minutes/day at a relatively low intensity of exercise while they receive cycling skill instructions. As their overall level of fitness and exercise skill improve, the intensity and duration of exercise will increase to 40-45 minutes/day at a moderate intensity of 70-75% of maximal heart rate. Exercise training will be performed three days per week.
Receives: Behavioral: Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Arterial Compliance

    Central Arterial Compliance: Common carotid artery diameter will be measured from the images derived from an ultrasound machine (Philips HDI-5000, Bothel, WA) equipped with a high-resolution linear-array transducer as previously described. A longitudinal image of the cephalic portion of the common carotid artery will be acquired 1-2 cm proximal to the carotid bulb with the transducer placed at 90 degrees to the vessel. The images will be analyzed with Vascular Tools 5 image analyses software. Similarly, intima-media thickness will be measured at end diastole as previously described. The combination of ultrasound imaging of a common carotid artery with simultaneous tonometric-obtained arterial pressure waveforms from the contralateral artery permits noninvasive determination of carotid artery compliance. Arterial compliance is a function of the increase in arterial pressure and a corresponding increase in cross-sectional area.

    Measured: three months

  2. Inflammatory Markers

    Fasted state, venous blood samples will be obtained to assess biological markers of inflammation. Serum C-reactive protein (CRP) will be assayed using ELISA (Alpha Diagnostics; San Antonio, TX). Inflammatory cytokines including Interleukin-6 (IL-6), TNF-α, and soluble receptor 1 (sTNFR1) will be analyzed from serum samples using a multiplex assay system (Bioplex, BioRad; Hercules, CA)

    Measured: three months

  3. Flow-Mediated Dilatation

    Flow-Mediated Dilatation is a non-invasive method to assess vascular endothelial function as previously described. Brachial artery diameters and blood flow velocity will be measured from images derived from a Doppler ultrasound machine equipped with a high-resolution linear array transducer. A longitudinal image of the brachial artery will be acquired 5-10 cm proximal to the antecubital fossa. A blood pressure cuff will be placed on the forearm 3-5 cm distal to the antecubital fossa. The cuff will be inflated to 100 mmHg above resting systolic blood pressure for 5 minutes. After cuff deflation, ultrasound-derived measurements of the brachial artery diameters and blood velocity will be taken for 3 minutes. FMD will be calculated as a percent increase in brachial artery diameter at the post-blood flow occlusion compared with the pre-blood flow occlusion.

    Measured: three months

Secondary outcomes (5)

  1. Mobility

    Six-minute walk distance will be used for a measure of mobility and functional status. Participants will be instructed to walk as far as possible on a flat, indoor surface.

    Measured: three month

  2. Muscular Strength

    Bilateral isometric quadriceps strength will be measured in order to evaluate the impact of exercise intervention on lower body strength. Grip strength will also be measured using standard grip strength dynamometer.

    Measured: three months

  3. Body Mass and Composition

    Body mass will be measured to the nearest 0.1 kg with a physicians' balance scale (SECA, Hamburg, Germany). Body composition will be determined using dual-energy x-ray absorptiometry (DEXA)(GE Lunar Radiation, Madison, WI).

    Measured: three months

  4. Self-Reported Physical Function and Pain

    A self-report questionnaire, the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) will be used to assess the degree of difficulty in performing activities of daily living. It consists of 17 questions that generate a summary score ranging from 0-68, with higher scores indicating increased disease severity.

    Measured: three months

  5. Health-Related Quality of Life

    Participants will complete the Short Form Health Survey (SF-36) questionnaire. The SF-36 survey consists of two subscales including physical health and mental health.

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJul 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01836380
Sponsor's protocol ID
NOA26752611
Acronym
OA
Status last verified
Mar 2015
First submitted
16 Apr 2013
Last updated
26 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Alkatan M, Baker JR, Machin DR, Park W, Akkari AS, Pasha EP, Tanaka H. Improved Function and Reduced Pain after Swimming and Cycling Training in Patients with Osteoarthritis. J Rheumatol. 2016 Mar;43(3):666-72. doi: 10.3899/jrheum.151110. Epub 2016 Jan 15.

    PubMed 26773104

  • Alkatan M, Machin DR, Baker JR, Akkari AS, Park W, Tanaka H. Effects of Swimming and Cycling Exercise Intervention on Vascular Function in Patients With Osteoarthritis. Am J Cardiol. 2016 Jan 1;117(1):141-5. doi: 10.1016/j.amjcard.2015.10.017. Epub 2015 Oct 22.

    PubMed 26541906

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Training in people with Osteoarthritis, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Arterial Compliance (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01836380, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.

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